EU CPMP Plenary Meeting In February

26 February 1996

At its 13th plenary meeting, held on february 13-15 at the European Medicines Evaluation Agency, the European Commission's Committee for Proprietary Medicinal Products:

- adopted positive opinions by consensus for four medicinal products corresponding to three new substances under the centralized procedure, including three submitted during 1995. These opinions will be forwarded to the Commission shortly;

- adopted by consensus a positive opinion for the first application for a type II variation procedure for a recent European Marketing Authorization. Positive opinions for 13 new medicinal products (four from new centralized procedures and nine from ex-concertation procedures) have been adopted by consensus since May 1995. The Committee also noted that the Commission has now granted EMAs to Schering-Plough's Fareston (toremifene) and Roche's Cellcept (mycophenolate mofetil); see also page 21;

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